Bone treatment systems and methods

ABSTRACT

The present invention relates in certain embodiments to medical devices for treating vertebral compression fractures. More particularly, embodiments of the invention relate to instruments and methods for controllably restoring vertebral body height by controlling the flow of bone cement into the interior of a vertebra and the application of forces causes by the cement flow. An exemplary system utilizes Rf energy in combination a conductive bone cement for selectively polymerizing the inflow plume to increase the viscosity of the cement. In one aspect of the invention, the system utilizes a controller to control bone cement flow parameters to either allow or disallow cement interdigitation into cancellous bone. A method of the invention includes pulsing the flows of bone cement wherein high acceleration of the flow pulses can apply expansion forces across the surface of the cement plume to reduce a vertebral fracture.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/786,362, filed May 24, 2010, now U.S. Pat. No. 8,348,955, which is acontinuation of U.S. application Ser. No. 11/209,035, filed Aug. 22,2005, now U.S. Pat. No. 7,722,620, which is a continuation-in-part ofU.S. application Ser. No. 11/208,448, filed Aug. 20, 2005, now U.S. Pat.No. 7,717,918, which is a continuation-in-part of U.S. application Ser.No. 11/196,045, filed Aug. 2, 2005, now U.S. Pat. No. 8,070,753, whichis a continuation-in-part of U.S. application Ser. No. 11/165,652, filedJun. 24, 2005, now U.S. Pat. No. 7,559,932, which claims the benefit ofU.S. Provisional Application Ser. No. 60/633,509, filed Dec. 6, 2004.This application is also related to U.S. patent application Ser. No.11/165,651, filed Jun. 24, 2005, now U.S. Pat. No. 7,678,116. The entirecontents of all of the above applications are hereby incorporated byreference and should be considered a part of this specification.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates in certain embodiments to medical devicesfor treating osteoplasty procedures such as vertebral compressionfractures. More particularly, embodiments of the invention relate toinstruments and methods for controllably restoring vertebral body heightby controlling bone cement flows into the interior of a vertebra. Anexemplary system utilizes Rf energy in combination a conductive bonecement and a controller for controlling cement flow parameters andenergy delivery parameters to provide pulsed cement flows with highacceleration rates for applying expansion forces to the bone and forcontrolling the geometry of the bone cement.

2. Description of the Related Art

Osteoporotic fractures are prevalent in the elderly, with an annualestimate of 1.5 million fractures in the United States alone. Theseinclude 750,000 vertebral compression fractures (VCFs) and 250,000 hipfractures. The annual cost of osteoporotic fractures in the UnitedStates has been estimated at $13.8 billion. The prevalence of VCFs inwomen age 50 and older has been estimated at 26%. The prevalenceincreases with age, reaching 40% among 80-year-old women. Medicaladvances aimed at slowing or arresting bone loss from aging have notprovided solutions to this problem. Further, the population affectedwill grow steadily as life expectancy increases. Osteoporosis affectsthe entire skeleton but most commonly causes fractures in the spine andhip. Spinal or vertebral fractures also cause other serious sideeffects, with patients suffering from loss of height, deformity andpersistent pain which can significantly impair mobility and quality oflife. Fracture pain usually lasts 4 to 6 weeks, with intense pain at thefracture site. Chronic pain often occurs when one vertebral level isgreatly collapsed or multiple levels are collapsed.

Postmenopausal women are predisposed to fractures, such as in thevertebrae, due to a decrease in bone mineral density that accompaniespostmenopausal osteoporosis. Osteoporosis is a pathologic state thatliterally means “porous bones”. Skeletal bones are made up of a thickcortical shell and a strong inner meshwork, or cancellous bone, of withcollagen, calcium salts and other minerals. Cancellous bone is similarto a honeycomb, with blood vessels and bone marrow in the spaces.Osteoporosis describes a condition of decreased bone mass that leads tofragile bones which are at an increased risk for fractures. In anosteoporosis bone, the sponge-like cancellous bone has pores or voidsthat increase in dimension making the bone very fragile. In young,healthy bone tissue, bone breakdown occurs continually as the result ofosteoclast activity, but the breakdown is balanced by new bone formationby osteoblasts. In an elderly patient, bone resorption can surpass boneformation thus resulting in deterioration of bone density. Osteoporosisoccurs largely without symptoms until a fracture occurs.

Vertebroplasty and kyphoplasty are recently developed techniques fortreating vertebral compression fractures. Percutaneous vertebroplastywas first reported by a French group in 1987 for the treatment ofpainful hemangiomas. In the 1990's, percutaneous vertebroplasty wasextended to indications including osteoporotic vertebral compressionfractures, traumatic compression fractures, and painful vertebralmetastasis. Vertebroplasty is the percutaneous injection of PMMA(polymethylmethacrylate) into a fractured vertebral body via a trocarand cannula. The targeted vertebrae are identified under fluoroscopy. Aneedle is introduced into the vertebrae body under fluoroscopic control,to allow direct visualization. A bilateral transpedicular (through thepedicle of the vertebrae) approach is typical but the procedure can bedone unilaterally. The bilateral transpedicular approach allows for moreuniform PMMA infill of the vertebra.

In a bilateral approach, approximately 1 to 4 ml of PMMA is used on eachside of the vertebra. Since the PMMA needs to be is forced into thecancellous bone, the techniques require high pressures and fairly lowviscosity cement. Since the cortical bone of the targeted vertebra mayhave a recent fracture, there is the potential of PMMA leakage. The PMMAcement contains radiopaque materials so that when injected under livefluoroscopy, cement localization and leakage can be observed. Thevisualization of PMMA injection and extravasion are critical to thetechnique—and the physician terminates PMMA injection when leakage isevident. The cement is injected using syringes to allow the physicianmanual control of injection pressure.

Kyphoplasty is a modification of percutaneous vertebroplasty.Kyphoplasty involves a preliminary step consisting of the percutaneousplacement of an inflatable balloon tamp in the vertebral body. Inflationof the balloon creates a cavity in the bone prior to cement injection.The proponents of percutaneous kyphoplasty have suggested that highpressure balloon-tamp inflation can at least partially restore vertebralbody height. In kyphoplasty, some physicians state that PMMA can beinjected at a lower pressure into the collapsed vertebra since a cavityexists, when compared to conventional vertebroplasty.

The principal indications for any form of vertebroplasty areosteoporotic vertebral collapse with debilitating pain. Radiography andcomputed tomography must be performed in the days preceding treatment todetermine the extent of vertebral collapse, the presence of epidural orforaminal stenosis caused by bone fragment retropulsion, the presence ofcortical destruction or fracture and the visibility and degree ofinvolvement of the pedicles.

Leakage of PMMA during vertebroplasty can result in very seriouscomplications including compression of adjacent structures thatnecessitate emergency decompressive surgery. See “Anatomical andPathological Considerations in Percutaneous Vertebroplasty andKyphoplasty: A Reappraisal of the Vertebral Venous System”, Groen, R. etal, Spine Vol. 29, No. 13, pp 1465-1471 2004. Leakage or extravasion ofPMMA is a critical issue and can be divided into paravertebral leakage,venous infiltration, epidural leakage and intradiscal leakage. Theexothermic reaction of PMMA carries potential catastrophic consequencesif thermal damage were to extend to the dural sac, cord, and nerveroots. Surgical evacuation of leaked cement in the spinal canal has beenreported. It has been found that leakage of PMMA is related to variousclinical factors such as the vertebral compression pattern, and theextent of the cortical fracture, bone mineral density, the interval frominjury to operation, the amount of PMMA injected and the location of theinjector tip. In one recent study, close to 50% of vertebroplasty casesresulted in leakage of PMMA from the vertebral bodies. See Hyun-Woo Doet al, “The Analysis of Polymethylmethacrylate Leakage afterVertebroplasty for Vertebral Body Compression Fractures”, Jour. ofKorean Neurosurg. Soc. Vol. 35, No. 5 (May 2004) pp. 478-82,(http://www.jkns.or.kr/htm/abstract.asp?no=0042004086).

Another recent study was directed to the incidence of new VCFs adjacentto the vertebral bodies that were initially treated. Vertebroplastypatients often return with new pain caused by a new vertebral bodyfracture. Leakage of cement into an adjacent disc space duringvertebroplasty increases the risk of a new fracture of adjacentvertebral bodies. See Am. J. Neuroradiol. 2004 February; 25(2):175-80.The study found that 58% of vertebral bodies adjacent to a disc withcement leakage fractured during the follow-up period compared with 12%of vertebral bodies adjacent to a disc without cement leakage.

Another life-threatening complication of vertebroplasty is pulmonaryembolism. See Bernhard, J. et al, “Asymptomatic diffuse pulmonaryembolism caused by acrylic cement: an unusual complication ofpercutaneous vertebroplasty”, Ann. Rheum. Dis. 2003; 62:85-86. Thevapors from PMMA preparation and injection also are cause for concern.See Kirby, B, et al., “Acute bronchospasm due to exposure topolymethylmethacrylate vapors during percutaneous vertebroplasty”, Am.J. Roentgenol. 2003; 180:543-544.

In both higher pressure cement injection (vertebroplasty) andballoon-tamped cementing procedures (kyphoplasty), the methods do notprovide for well controlled augmentation of vertebral body height. Thedirect injection of bone cement simply follows the path of leastresistance within the fractured bone. The expansion of a balloon appliesalso compacting forces along lines of least resistance in the collapsedcancellous bone. Thus, the reduction of a vertebral compression fractureis not optimized or controlled in high pressure balloons as forces ofballoon expansion occur in multiple directions.

In a kyphoplasty procedure, the physician often uses very high pressures(e.g., up to 200 or 300 psi) to inflate the balloon which crushes andcompacts cancellous bone. Expansion of the balloon under high pressuresclose to cortical bone can fracture the cortical bone, typically theendplates, which can cause regional damage to the cortical bone with therisk of cortical bone necrosis. Such cortical bone damage is highlyundesirable as the endplate and adjacent structures provide nutrientsfor the disc.

Kyphoplasty also does not provide a distraction mechanism capable of100% vertebral height restoration. Further, the kyphoplasty balloonsunder very high pressure typically apply forces to vertebral endplateswithin a central region of the cortical bone that may be weak, ratherthan distributing forces over the endplate.

There is a general need to provide bone cements and methods for use intreatment of vertebral compression fractures that provide a greaterdegree of control over introduction of cement and that provide betteroutcomes. The present invention meets this need and provides severalother advantages in a novel and nonobvious manner.

SUMMARY OF THE INVENTION

Certain embodiments of the invention provide systems and methods forutilizing Rf energy in combination with a bone cement that carries anelectrically conductive filler. A computer controller controls cementinflow parameters and energy delivery parameters for selectivelypolymerizing the cement inflow plume to thereby control the direction offlow and the ultimate geometry of a flowable, in-situ hardenable cementcomposite. The system and method further includes means for sealingtissue in the interior of a vertebra to prevent migration of monomers,fat or emboli into the patient's bloodstream.

These and other objects of the present invention will become readilyapparent upon further review of the following drawings andspecification.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to better understand the invention and to see how it may becarried out in practice, some preferred embodiments are next described,by way of non-limiting examples only, with reference to the accompanyingdrawings, in which like reference characters denote correspondingfeatures consistently throughout similar embodiments in the attacheddrawings.

FIG. 1 is a schematic side view of a spine segment showing a vertebrawith a compression fracture and an introducer, in accordance with oneembodiment disclosed herein.

FIG. 2A is a schematic perspective view of a system for treating bone,in accordance with one embodiment.

FIG. 2B is a schematic perspective sectional view of a working end ofthe introducer taken along line 2B-2B of FIG. 2A.

FIG. 3A is a schematic perspective view of a working end of a probe, inaccordance with one embodiment.

FIG. 3B is a schematic perspective view of a working end of a probe, inaccordance with another embodiment.

FIG. 3C is a schematic perspective view of a working end of a probe, inaccordance with yet another embodiment.

FIG. 4 is a schematic sectional side view of one embodiment of a workingend of a probe, in accordance with one embodiment.

FIG. 5A is a schematic side view of a probe inserted into a vertebralbody and injecting flowable fill material into the vertebral body.

FIG. 5B is a schematic side view of the probe in FIG. 5A injecting arelatively high viscosity volume of flowable fill material into thevertebral body, in accordance with one embodiment of the presentinvention.

FIG. 6 is a schematic perspective view of a system for treating bone, inaccordance with another embodiment.

FIG. 7A is a schematic sectional view of a fill material, in accordancewith one embodiment.

FIG. 7B is a schematic sectional view of a fill material, in accordancewith another embodiment.

FIG. 8A is a schematic perspective view of a system for treating bone,in accordance with another embodiment.

FIG. 8B is a schematic perspective view of the system in FIG. 8A,injecting an additional volume of fill material into a vertebral body.

FIG. 9A is a schematic sectional view of one step in a method fortreating bone, in accordance with one embodiment.

FIG. 9B is a schematic sectional view of another step in a method fortreating bone, in accordance with one embodiment.

FIG. 9C is a schematic sectional view of still another step in a methodfor treating bone, in accordance with one embodiment.

FIG. 10A is a schematic sectional view of a step in a method fortreating bone, in accordance with another embodiment.

FIG. 10B is a schematic sectional view of another step in a method fortreating bone, in accordance with another embodiment.

FIG. 11A is a schematic perspective view of a system for treating bone,in accordance with another embodiment.

FIG. 11B is a schematic perspective view of the system in FIG. 11A,applying energy to a fill material.

FIG. 12 is a schematic perspective view of a system for treating bone,in accordance with another embodiment.

FIG. 13 is a schematic view of another embodiment of a bone cementdelivery system together with an aspiration source a working end of anintroducer, in accordance with one embodiment.

FIG. 14A is a sectional view of a working end of an introducer as inFIG. 13 showing the orientation of a cement injection port in avertebra.

FIG. 14B is a sectional view of the working end of FIG. 14A showing aninitial inflow of bone cement.

FIG. 14C is a sectional view of the working end of FIG. 14B showing anadditional inflow of bone cement to reduces a vertebral fracture.

FIG. 15A is a sectional view of a vertebra depicting a first mode ofoperation wherein an initial flow of bone cement is provided underselected flow parameters that allow cement interdigitation intocancellous bone.

FIG. 15B is a sectional view of a vertebra similar to FIG. 15A depictinga second mode of operation wherein cement flows are provided in a highacceleration pulse that disallows cement interdigitation into cancellousbone.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

FIG. 1 illustrates one embodiment of the invention for treating a spinesegment in which a vertebral body 90 has a wedge compression fractureindicated at 94. In one embodiment, the systems and methods of theinvention are directed to safely introducing a bone fill material intocancellous bone of the vertebra without extravasion of fill material inunwanted directions (i) to prevent micromotion in the fracture foreliminating pain, and (ii) to support the vertebra and increasevertebral body height. Further, the invention includes systems andmethods for sealing cancellous bone (e.g., blood vessels, fatty tissuesetc.) in order to prevent monomers, fat, fill material and other embolifrom entering the venous system during treatment.

FIG. 1 illustrates a fractured vertebra and bone infill system 100 whichincludes probe 105 having a handle end 106 extending to an elongatedintroducer 110A and working end 115A, shown in FIG. 2A. The introduceris shown introduced through pedicle 118 of the vertebra for accessingthe osteoporotic cancellous bone 122 (See FIG. 2A). The initial aspectsof the procedure are similar to conventional percutaneous vertebroplastywherein the patient is placed in a prone position on an operating table.The patient is typically under conscious sedation, although generalanesthesia is an alternative. The physician injects a local anesthetic(e.g., 1% Lidocaine) into the region overlying the targeted pedicle orpedicles as well as the periosteum of the pedicle(s). Thereafter, thephysician uses a scalpel to make a 1 to 5 mm skin incision over eachtargeted pedicle. Thereafter, the introducer 110A is advanced throughthe pedicle into the anterior region of the vertebral body, whichtypically is the region of greatest compression and fracture. Thephysician confirms the introducer path posterior to the pedicle, throughthe pedicle and within the vertebral body by anteroposterior and lateralX-Ray projection fluoroscopic views. The introduction of infill materialas described below can be imaged several times, or continuously, duringthe treatment depending on the imaging method.

It should be appreciated that the introducer also can be introduced intothe vertebra from other angles, for example, along axis 113 through thewall of the vertebral body 114 as in FIG. 1 or in an anterior approach(not shown). Further, first and second cooperating introducers can beused in a bilateral transpedicular approach. Additionally, any mechanismknown in the art for creating an access opening into the interior of thevertebral body 90 can be used, including open surgical procedures.

DEFINITIONS

“Bone fill material, infill material or composition” includes itsordinary meaning and is defined as any material for infilling a bonethat includes an in-situ hardenable material. The fill material also caninclude other “fillers” such as filaments, microspheres, powders,granular elements, flakes, chips, tubules and the like, autograft orallograft materials, as well as other chemicals, pharmacological agentsor other bioactive agents.

“Flowable material” includes its ordinary meaning and is defined as amaterial continuum that is unable to withstand a static shear stress andresponds with an irrecoverable flow (a fluid) —unlike an elasticmaterial or elastomer that responds to shear stress with a recoverabledeformation. Flowable material includes fill material or composites thatinclude a fluid (first) component and an elastic or inelastic material(second) component that responds to stress with a flow, no matter theproportions of the first and second component, and wherein the aboveshear test does not apply to the second component alone.

An “elastomer” includes its ordinary meaning and is defined as materialhaving to some extent the elastic properties of natural rubber whereinthe material resumes or moves toward an original shape when a deformingforce is removed.

“Substantially” or “substantial” mean largely but not entirely. Forexample, substantially may mean about 10% to about 99.999%, about 25% toabout 99.999% or about 50% to about 99.999%.

“Osteoplasty” includes its ordinary meaning and means any procedurewherein fill material is delivered into the interior of a bone.

“Vertebroplasty” includes its ordinary meaning and means any procedurewherein fill material is delivered into the interior of a vertebra.

Now referring to FIGS. 2A and 2B, the end of introducer 110A is shownschematically after being introduced into cancellous bone 122 with aninflow of fill material indicated at 120. The cancellous bone can be inany bone, for example in a vertebra. It can be seen that the introducer110A and working end 115A comprise a sleeve or shaft that is preferablyfabricated of a metal having a flow channel 118 extending therethroughfrom the proximal handle end 106 (see FIG. 1). In one embodiment, theintroducer shaft is a stainless steel tube 123 having an outsidediameter ranging between about 3.5 and 4.5 mm, but other dimensions arepossible. As can be seen in FIGS. 2A and 3A, the flow channel 118 canterminate in a single distal open termination or outlet 124 a in theworking end 115A, or there can be a plurality of flow outlets or ports124 b configured angularly about the radially outward surfaces of theworking end 115A of FIG. 3B. The outlets in the working end thus allowfor distal or radial ejection of fill material, or a working end canhave a combination of radial and distal end outlets. As can be seen inFIG. 3C, the distal end of working end 115A also can provide an angleddistal end outlet 124 c for directing the flow of fill material from theoutlet by rotating the working end.

In FIGS. 2A and 2B, it can be seen that system 100 includes a remoteenergy source 125A and a controller 125B that are operatively coupled toan energy emitter 128 in working end 115A for applying energy to fillmaterial 120 contemporaneous with and subsequent to ejection of the fillmaterial from the working end. As shown in FIG. 2A, a preferred energysource 125A is a radiofrequency (Rf) source known in the art that isconnected to at least one electrode (132 a and 132 b in FIGS. 2A and 2B)in contact with injected fill material 120 that carries a radiosensitivecomposition therein. It is equally possible to use other remote energysources and emitters 128 in the working end which fall within the scopeof the invention, such as (i) an electrical source coupled to aresistive heating element in the working end, (ii) a light energy source(coherent or broadband) coupled to an optical fiber or other lightchannel terminating in the working end; (iii) an ultrasound sourcecoupled to an emitter in the working end; or a (iv) or a microwavesource coupled to an antenna in the working end. In still anotherembodiment, the energy source can be a magnetic source. The fillmaterial is configured with an energy-absorbing material or anenergy-transmitting material that cooperates with energy delivery from aselected energy source. For example, the energy-absorbing orenergy-transmitting material can be a radiosensitive or conductivematerial for cooperating with an Rf source, chromophores for cooperatingwith a light source, ferromagnetic particles for cooperating with amagnetic source, and the like. In one embodiment, the fill material 120can include a composition having an energy-absorbing property and anenergy-transmitting property for cooperating with the remote energysource 125A. For example, the composition can absorb energy from theremote energy source 125A for polymerizing the composite or transmitenergy for heating tissue adjacent to the composite.

As can be understood from FIGS. 2A and 2B, the exemplary introducer 110Ais operatively coupleable to a source 145 of bone fill material 120together with a pressure source or mechanism 150 that operates on thesource of fill material to deliver the fill material 120 through theintroducer 110A into a bone (see arrows). The pressure source 150 cancomprise any type of pump mechanism, such as a piston pump, screw pumpor other hydraulic pump mechanism. In FIG. 2B, the pump mechanism isshown as a piston or plunger 152 that is slidable in channel 118 ofintroducer 110A. In one embodiment, the pressure source 150 includes acontroller 150B that controls the pressure applied by the pressuresource 150. For example, where the pressure source 150 is a piston pumpor screw pump that is motor driven, the controller 150B can adjust themotor speed to vary the pressure applied by the pressure source 150 tothe inflow of the bone fill material 120. In one embodiment, thecontroller 150B also controls the volume of the bone fill material 120that is introduced to a bone portion. In another embodiment, thecontroller 150B, or a separate controller, can also control the volumeof bone fill material 120 introduced into the bone portion. For example,the controller 150B can operate a valve associated with the bone fillsource 145 to selectively vary the valve opening, thus varying thevolume of bone fill material 120 introduced to the bone portion.

As shown in FIGS. 2A and 2B, the introducer 110A preferably has anelectrically and thermally insulative interior sleeve 154 that definesinterior flow channel 118. The sleeve can be any suitable polymer knownin the art such as PEEK, Teflon™ or a polyimide. As can be seen in FIG.2B, interior sleeve 154 carries conductive surfaces that function asenergy emitter 128, and more particularly comprise spaced apart opposingpolarity electrodes 132 a and 132 b. The electrodes 132 a and 132 b canhave any spaced apart configuration and are disposed about the distaltermination of channel 118 or about the surfaces of outlet 124 a. Theelectrode configuration alternatively can include a first electrode inthe interior of channel 118 and a second electrode on an exterior ofintroducer 110A. For example, the metallic sleeve 123 or a distalportion thereof can comprise one electrode. In a preferred embodiment,the electrodes 132 a and 132 b are connected to Rf energy source 125Aand controller 125B by electrical cable 156 with (+) and (−) electricalleads 158 a and 158 b therein that extend through the insulative sleeve154 to the opposing polarity electrodes. In one embodiment, theelectrical cable 156 is detachably coupled to the handle end 106 ofprobe 105 by male-female plug (not shown). The electrodes 132 a and 132b can be fabricated of any suitable materials known to those skilled inthe art, such as stainless steels, nickel-titanium alloys and alloys ofgold, silver platinum and the like.

In one embodiment, not shown, the working end 115A can also carry anysuitable thermocouple or temperature sensor for providing data tocontroller 125B relating to the temperature of the fill material 120during energy delivery. One or more thermocouples may be positioned atthe distal tip of the introducer, or along an outer surface of theintroducer and spaced from the distal end, in order to providetemperature readings at different locations within the bone. Thethermocouple may also be slideable along the length of the introducer.In another embodiment, the working end can have at least one side port(not shown) in communication with a coolant source, the port configuredto provide the coolant (e.g., saline) therethrough into the cancellousbone 122 to cool the cancellous bone in response to a temperaturereading from the temperature sensor.

Now turning to FIG. 4, the sectional view of working end 115Aillustrates the application of energy to fill material 120 as it beingejected from outlet 124 a. The fill material 120 in the proximal portionof channel 118 can be a low viscosity flowable material such as atwo-part curable polymer that has been mixed (e.g., PMMA) but withoutany polymerization, for example, having a viscosity of less than about50,000 cps. Such a low viscosity fill material allows for simplifiedlower pressure injection through introducer 110A. Further, the systemallows the use of a low viscosity fill material 120 which can save greatdeal of time for the physician.

In a preferred embodiment, it is no longer necessary to wait for thebone cement to partly polymerize before injection. As depicted in FIG.4, energy delivery at selected parameters from electrodes 132 a and 132b to fill material 120 contemporaneous with its ejection from outlet 124a selectively alters a property of fill material indicated at 120′. Inone embodiment, the altered flow property is viscosity. For example, theviscosity of the fill material 120′ can be increased to a higherviscosity ranging from about 100,000 cps or more, 1,000,000 cps or more,to 2,000,000 cps or more. In another embodiment, the flow property isYoung's modulus. For example, the Young's modulus of the fill material120′ can be altered to be between about 10 kPa and about 10 GPa. Instill another embodiment, the flow property can be one of durometer,hardness and compliance.

Preferably, the fill material carries a radiosensitive composition forcooperating with the Rf source 125A, as further described below. At apredetermined fill material flow rate and at selected Rf energy deliveryparameters, the altered fill material 120′ after ejection can comprisean increased viscosity material or an elastomer. At yet anotherpredetermined fill material flow rate and at other Rf energy deliveryparameters, the altered fill material 120′ after ejection can comprise asubstantially solid material. In the system embodiment utilized forvertebroplasty as depicted in FIGS. 2A and 5B, the controller is adaptedfor delivering Rf energy contemporaneous with the selected flow rate offill material to provide a substantially high viscosity fill materialthat is still capable of permeating cancellous bone. In otherosteoplasty procedures such as treating necrosis of a bone, the systemcontroller 125B can be adapted to provide much harder fill material 120′upon ejection from outlet 124 a. Further, the system can be adapted toapply Rf energy to the fill material continuously, or in a pulse mode orin any selected intervals based on flow rate, presets, or in response tofeedback from temperature sensors, impedance measurements or othersuitable signals known to those skilled in the art.

In one embodiment, the controller 125B includes algorithms for adjustingpower delivery applied by the energy source 125A. For example, in oneembodiment the controller 125B includes algorithms for adjusting powerdelivery based on impedance measurements of the fill material 120′introduced to the bone portion. In another embodiment, the controller125B includes algorithms for adjusting power delivery based on thevolume of bone fill material 120 delivered to the bone portion. In stillanother embodiment, the controller 125B includes algorithms foradjusting power delivery based on the temperature of the bone fillmaterial 120′ introduced to the bone portion.

FIGS. 5A and 5B are views of a vertebra 90 that are useful forexplaining relevant aspects of one embodiment of the invention whereinworking end 110A is advanced into the region of fracture 94 incancellous bone 122. FIG. 5A indicates system 100 being used to injectflow material 120 into the vertebra with the flow material having aviscosity similar to conventional vertebroplasty or kyphoplasty, forexample having the consistency of toothpaste. FIG. 5A depicts thesituation wherein high pressure injection of a low viscosity materialcan simply follow paths of least resistance along a recent fractureplane 160 to migrate anteriorly in an uncontrolled manner. The migrationof fill material could be any direction, including posteriorly towardthe spinal canal or into the disc space depending on the nature of thefracture.

FIG. 5B illustrates system 100 including actuation of Rf source 125A bycontroller 125B to contemporaneously heat the fill material to ejectaltered fill material 120′ with a selected higher viscosity intocancellous bone 122, such as the viscosities described above. With aselected higher viscosity, FIG. 5B depicts the ability of the system toprevent extravasion of fill material and to controllably permeate andinterdigitate with cancellous bone 122, rather than displacingcancellous bone, with a plume 165 that engages cortical bone vertebralendplates 166 a and 166 b. The fill material broadly engages surfaces ofthe cortical endplates to distribute pressures over the endplates. In apreferred embodiment, the fill material controllably permeatescancellous bone 122 and is ejected at a viscosity adequate tointerdigitate with the cancellous bone 122. Fill material with aviscosity in the range of about 100,000 cps to 2,000,000 cps may beejected, though even lower or higher viscosities may also be sufficient.The Rf source may selectively increase the viscosity of the fillmaterial by about 10% or more as it is ejected from the introducer 115A.In other embodiments, the viscosity may be increased by about 20%, 50%,100%, 500% or 1000% or more.

Still referring to FIG. 5B, it can be understood that continued inflowsof high viscosity fill material 120′ and the resultant expansion ofplume 165 will apply forces on endplates 166 a and 166 b to at leastpartially restore vertebral height. It should be appreciated that theworking end 115A can be translated axially between about the anteriorthird of the vertebral body and the posterior third of the vertebralbody during the injection fill material 120′, as well as rotating theworking end 115A which can be any of the types described above (FIGS.3A-3C).

FIG. 6 is a schematic view of an alternative embodiment of system 100wherein Rf source 125A and controller 125B are configured to multiplexenergy delivery to provide additional functionality. In one mode ofoperation, the system functions as described above and depicted in FIGS.4 and 5B to alter flow properties of flowable fill material 120′ as itis ejected from working end 115A. As can be seen in FIG. 6, the systemfurther includes a return electrode or ground pad indicated at 170. Thusthe system can be operated in a second mode of operation whereinelectrodes 132 a and 132 b are switched to a common polarity (or thedistal portion of sleeve 123 can comprise such an electrode) to functionin a mono-polar manner in conjunction with ground pad 170. This secondmode of operation advantageously creates high energy densities about thesurface of plume 165 to thereby ohmically heat tissue at the interfaceof the plume 165 and the body structure.

In FIG. 6, the ohmically heated tissue is indicated at 172, wherein thetissue effect is coagulation of blood vessels, shrinkage of collagenoustissue and generally the sealing and ablation of bone marrow,vasculature and fat within the cancellous bone. The Rf energy levels canbe set at a sufficiently high level to coagulate, seal or ablate tissue,with the controller delivering power based, for example, on impedancefeedback which will vary with the surface area of plume 165. Ofparticular interest, the surface of plume 165 is used as an electrodewith an expanding wavefront within cancellous bone 122. Thus, thevasculature within the vertebral body can be sealed by controlled ohmicheating at the same time that fill material 120′ is permeating thecancellous bone. Within the vertebral body are the basivertebral(intravertebral) veins which are paired valveless veins connecting withnumerous venous channels within the vertebra (pars spongiosa/red bonemarrow). These basivertebral veins drain directly into the externalvertebral venous plexus (EVVP) and the superior and inferior vena cava.The sealing of vasculature and the basivertebral veins is particularlyimportant since bone cement and monomer embolism has been frequentlyobserved in vertebroplasty and kyphoplasty cases (see “Anatomical andPathological Considerations in Percutaneous Vertebroplasty andKyphoplasty: A Reappraisal of the Vertebral Venous System”, Groen, R. etal, Spine Vol. 29, No. 13, pp 1465-1471 2004). It can be thus understoodthat the method of using the system 100 creates and expands a“wavefront” of coagulum that expands as the plume 165 of fill materialexpands. The expandable coagulum layer 172, besides sealing the tissuefrom emboli, contains and distributes pressures of the volume of infillmaterial 120′ about the plume surface.

The method depicted in FIG. 6 provides an effective means for sealingtissue via ohmic (Joule) heating. It has been found that passive heattransfer from the exothermic reaction of a bone cement does notadequately heat tissue to the needed depth or temperature to sealintravertebral vasculature. In use, the mode of operation of the system100 in a mono-polar manner for ohmically heating and sealing tissue canbe performed in selected intervals alone or in combination with thebi-polar mode of operation for controlling the viscosity of the injectedfill material.

In general, one aspect of the vertebroplasty or osteoplasty method inaccordance with one of the embodiments disclosed herein allows forin-situ control of flows of a flowable fill material, and moreparticularly comprises introducing a working end of an introducer sleeveinto cancellous bone, ejecting a volume of flowable fill material havinga selected viscosity and contemporaneously applying energy (e.g., Rfenergy) to the fill material from an external source to thereby increasethe viscosity of at least portion of the volume to prevent fillextravasion. In a preferred embodiment, the system increases theviscosity by about 20% or more. In another preferred embodiment, thesystem increases the viscosity by about 50% or more.

In another aspect of one embodiment of a vertebroplasty method, thesystem 100 provides means for ohmically heating a body structure aboutthe surface of the expanding plume 165 of fill material to effectivelyseal intravertebral vasculature to prevent emboli from entering thevenous system. The method further provides an expandable layer ofcoagulum about the infill material to contain inflow pressures anddistribute further expansion forces over the vertebral endplates. In apreferred embodiment, the coagulum expands together with at least aportion of the infill material to engage and apply forces to endplatesof the vertebra.

Of particular interest, one embodiment of fill material 120 as used inthe systems described herein (see FIGS. 2A, 4, 5A-5B and 6) is acomposite comprising an in-situ hardenable or polymerizable cementcomponent 174 and an electrically conductive filler component 175 in asufficient volume to enable the composite to function as a dispersableelectrode (FIG. 6). In one type of composite, the conductive fillercomponent is any biocompatible conductive metal. In another type ofcomposite, the conductive filler component is a form of carbon. Thebiocompatible metal can include at least one of titanium, tantalum,stainless steel, silver, gold, platinum, nickel, tin, nickel titaniumalloy, palladium, magnesium, iron, molybdenum, tungsten, zirconium,zinc, cobalt or chromium and alloys thereof. The conductive fillercomponent has the form of at least one of filaments, particles,microspheres, spheres, powders, grains, flakes, granules, crystals,rods, tubules, nanotubes, scaffolds and the like. In one embodiment, theconductive filler includes carbon nanotubes. Such conductive fillercomponents can be at least one of rigid, non-rigid, solid, porous orhollow, with conductive filaments 176 a illustrated in FIG. 7A andconductive particles 176 b depicted in FIG. 7B.

In a preferred embodiment, the conductive filler comprises choppedmicrofilaments or ribbons of a metal as in FIG. 7A that have a diameteror a cross-section dimension across a major axis ranging between about0.0005″ and 0.01″. The lengths of the microfilaments or ribbons rangefrom about 0.01″ to 0.50″. The microfilaments or ribbons are ofstainless steel or titanium and are optionally coated with a thin goldlayer or silver layer that can be deposited by electroless platingmethods. Of particular interest, the fill material 120 of FIG. 7A has anin situ hardenable cement component 174 than has a first low viscosityand the addition of the elongated microfilament conductive fillercomponent 175 causes the composite 120 to have a substantially highapparent viscosity due to the high surface area of the microfilamentsand its interaction with the cement component 174. In one embodiment,the microfilaments are made of stainless steel, plated with gold, andhave a diameter of about 12 microns and a length of about 6 mm. Theother dimensions provided above and below may also be utilized for thesemicrofilaments.

In another embodiment of bone fill material 120, the conductive fillercomponent comprises elements that have a non-conductive core portionwith a conductive cladding portion for providing electrosurgicalfunctionality. The non-conductive core portions are selected from thegroup consisting of glass, ceramic or polymer materials. The claddingcan be any suitable conductive metal as described above that can bedeposited by electroless plating methods.

In any embodiment of bone fill material that uses particles,microspheres, spheres, powders, grains, flakes, granules, crystals orthe like, such elements can have a mean dimension across a principalaxis ranging from about 0.5 micron to 2000 microns. More preferably, themean dimension across a principal axis range from about 50 microns to1000 microns. It has been found that metal microspheres having adiameter of about 800 microns are useful for creating conductive bonecement that can function as an electrode.

In one embodiment, a conductive filler comprising elongatedmicrofilaments wherein the fill material has from about 0.5% to 20%microfilaments by weight. More preferably, the filaments are from about1% to 10% by weight of the fill material. In other embodiments whereinthe conductive filler comprises particles or spheres, the conductivefiller can comprise from about 5% of the total weight to about 80% ofthe weight of the material.

In an exemplary fill material 120, the hardenable component can be anyin-situ hardenable composition such as at least one of PMMA, monocalciumphosphate, tricalcium phosphate, calcium carbonate, calcium sulphate orhydroxyapatite.

Referring now to FIGS. 8A and 8B, an alternative method is shown whereinthe system 100 and method are configured for creating asymmetries inproperties of the infill material and thereby in the application offorces in a vertebroplasty. In FIG. 8A, the pressure mechanism 150 isactuated to cause injection of an initial volume or aliquot of fillmaterial 120′ that typically is altered in viscosity in working end 110Aas described above—but the method encompasses flows of fill materialhaving any suitable viscosity. The fill material is depicted in FIGS. 8Aand 8B as being delivered in a unilateral transpedicular approach, butany extrapedicular posterior approach is possible as well as anybilateral posterior approach. The system in FIGS. 8A-8B againillustrates a vertical plane through the fill material 120′ that flowsunder pressure into cancellous bone 122 with expanding plume orperiphery indicated at 165. The plume 165 has a three dimensionalconfiguration as can be seen in FIG. 8B, wherein the pressurized flowmay first tend to flow more horizontally that vertically. One embodimentof the method of the invention includes the physician translating theworking end slightly and/or rotating the working end so that flowoutlets 124 a are provided in a selected radial orientation. In apreferred embodiment, the physician intermittently monitors the flowsunder fluoroscopic imaging as described above.

FIG. 8B depicts a contemporaneous or subsequent energy-delivery step ofthe method wherein the physician actuates Rf electrical source 125A andcontroller 125B to cause Rf current delivery from at least one electrodeemitter 128 to cause ohmic (Joule) heating of tissue as well as internalheating of the inflowing fill material 120′. In this embodiment, theexterior surface of sleeve 123 is indicated as electrode or emitter 128with the proximal portion of introducer 110A having an insulator coating178. The Rf energy is preferably applied in an amount and for a durationthat coagulates tissue as well as alters a flowability property ofsurface portions 180 of the initial volume of fill material proximatethe highest energy densities in tissue.

In one preferred embodiment, the fill material 120 is particularlydesigned to create a gradient in the distribution of conductive fillerwith an increase in volume of material injected under high pressure intocancellous bone 122. This aspect of the method in turn can be usedadvantageously to create asymmetric internal heating of the fill volume.In this embodiment, the fill material 120 includes a conductive fillerof elongated conductive microfilaments 176 a (FIG. 7A). The filamentsare from about 2% to 5% by weight of the fill material, with thefilaments having a mean diameter or mean sectional dimension across aminor axis ranging between about 0.001″ and 0.010″ and a length rangingfrom about 1 mm to about 10 mm, more preferably about 1 mm to 5 mm. Inanother embodiment, the filaments have a mean diameter or a meandimension across a minor axis ranging between about 1 micron and 500microns, more preferably between about 1 micron and 50 microns, evenmore preferably between about 1 micron and 20 microns. It has been foundthat elongated conductive microfilaments 176 a result in resistance toflows thereabout which causes such microfilaments to aggregate away fromthe most active media flows that are concentrated in the center of thevertebra proximate to outlet 124 a. Thus, the conductive microfilaments176 a attain a higher concentration in the peripheral or surface portion180 of the plume which in turn will result in greater internal heatingof the fill portions having such higher concentrations of conductivefilaments. The active flows also are controlled by rotation ofintroducer 110A to eject the material preferentially, for examplelaterally as depicted in FIGS. 8A and 8B rather that vertically. Thehandle 106 of the probe 105 preferably has markings to indicate therotational orientation of the outlets 124 b.

FIG. 8A depicts the application of Rf energy in a monopolar mannerbetween electrode emitter 128 and ground pad 170, which thus causesasymmetric heating wherein surface portion 180 heating results ingreater polymerization therein. As can be seen in FIG. 8A, the volume offill material thus exhibits a gradient in a flowability property, forexample with surface region 180 having a higher viscosity than inflowingmaterial 120′ as it is ejected from outlet 124 a. In one embodiment, thegradient is continuous. Such heating at the plume periphery 165 cancreate an altered, highly viscous surface region 180. This step of themethod can transform the fill material to have a gradient in flowabilityin an interval of about 5 seconds to 500 seconds with surface portion180 being either a highly viscous, flowable layer or an elastomer thatis expandable. In preferred embodiments, the interval of energy deliveryrequired less than about 120 seconds to alter fill material to aselected asymmetric condition. In another aspect of the invention, theRf energy application for creating the gradient in flowability also canbe optimized for coagulating and sealing adjacent tissue.

The combination of the viscous surface portion 180 and the tissuecoagulum 172 may function as an in-situ created stretchable, butsubstantially flow-impervious, layer to contain subsequent high pressureinflows of fill material. Thus, the next step of the method of theinvention is depicted in FIG. 8B which includes injecting additionalfill material 120′ under high pressure into the interior of the initialvolume of fill material 120 that then has a highly viscous, expandablesurface. The viscous, expandable surface desirably surrounds cancellousbone By this means, the subsequent injection of fill material can expandthe fill volume to apply retraction forces on the vertebra endplates 166a and 166 b to provide vertical jacking forces, distracting corticalbone, for restoring vertebral height, as indicated by the arrows in FIG.8B. The system can generate forces capable of breaking callus incortical bone about a vertebral compression fracture when the fractureis less than completely healed.

In one embodiment, the method includes applying Rf energy to createhighly viscous regions in a volume of fill material and thereafterinjecting additional fill material 120 to controllably expand the fillvolume and control the direction of force application. The scope of themethod further includes applying Rf energy in multiple intervals orcontemporaneous with a continuous flow of fill material. The scope ofthe method also includes applying Rf in conjunction with imaging meansto prevent unwanted flows of the fill material. The scope of theinvention also includes applying Rf energy to polymerize and acceleratehardening of the entire fill volume after the desired amount of fillmaterial has been injected into a bone.

In another embodiment, the method includes creating Rf current densitiesin selected portions of the volume of fill material 120 to createasymmetric fill properties based on particular characteristics of thevertebral body. For example, the impedance variances in cancellous boneand cortical bone can be used to create varied Rf energy densities infill material 120 to create asymmetric properties therein. Continuedinjection of fill material 120 are thus induced to apply asymmetricretraction forces against cortical endplates 166 a and 166 b, whereinthe flow direction is toward movement or deformation of the lowerviscosity portions and away from the higher viscosity portions. In FIGS.9A-9C, it can be seen that in a vertebroplasty, the application of Rfenergy in a mono-polar manner as in FIG. 6 naturally and preferentiallycreates more highly viscous, deeper “altered” properties in surfaces ofthe lateral peripheral fill volumes indicated at 185 and 185′ and lessviscous, thinner altered surfaces in the superior and inferior regions186 and 186′ of fill material 120. This effect occurs since Rf currentdensity is localized about paths of least resistance which arepredominantly in locations proximate to highly conductive cancellousbone 122 a and 122 b. The Rf current density is less in locationsproximate to less conductive cortical bone indicated at 166 a and 166 b.Thus, it can be seen in FIG. 9B that the lateral peripheral portions 185and 185′ of the first flows of fill material 120 are more viscous andresistant to flow and expansion than the thinner superior and inferiorregions. In FIG. 9C, the asymmetrical properties of the initial flows offill material 120 allows the continued flows to apply retraction forcesin substantially vertical directions to reduce the vertebral fractureand increase vertebral height, for example from VH (FIG. 9B) to VH′ inFIG. 9C.

FIGS. 10A and 10B are schematic views that further depict a methodcorresponding to FIGS. 9B and 9C that comprises expanding cancellousbone for applying retraction forces against cortical bone, e.g.,endplates of a vertebra in a vertebroplasty. As can be seen in FIG. 10A,an initial volume of flowable fill material 120 is injected intocancellous bone wherein surface region 180 is altered as described aboveto be highly viscous or to comprise and elastomer that is substantiallyimpermeable to interior flows but still be expandable. The surfaceregion 180 surrounds subsequent flows of fill material 120′ whichinterdigitate with cancellous bone. Thereafter, as shown in FIG. 10B,continued high pressure inflow into the interior of the fill materialthereby expands the cancellous bone 122 together with the interdigitatedfill material 120′. As can be seen in FIG. 10B, the expansion ofcancellous bone 122 and fill material 120′ thus applies retractionforces to move cortical bone endplates 166 a and 166 b. The method ofexpanding cancellous bone can be used to reduce a bone fracture such asa vertebral compression fracture and can augment or restore the heightof a fractured vertebra. The system thus can be used to support retractand support cortical bone, and cancellous bone. The method can alsorestore the shape of an abnormal vertebra, such as one damaged by atumor.

After utilizing system 100 to introduce, alter and optionally hardenfill material 120 as depicted in FIGS. 9A-9C and 10A-10B, the introducer110A can be withdrawn from the bone. Alternatively, the introducer 110Acan have a release or detachment structure indicated at 190 forde-mating the working end from the proximal introducer portion asdescribed in U.S. patent application Ser. No. 11/130,843, filed May 16,2005, the entirety of which is hereby incorporated by reference.

Another system embodiment 200 for controlling flow directions and forcreating asymmetric properties is shown in FIGS. 11A and 11B, whereinfirst and second introducers 110A and 110B similar to those describedabove are used to introduce first and second independent volumes 202 aand 202 b of fill material 120 in a bilateral approach. In thisembodiment, the two fill volumes function as opposing polarityelectrodes in contact with electrodes 205 a and 205 b of the workingends. Current flow between the electrodes thus operates in a bi-polarmanner with the positive and negative polarities indicated by the (+)and (−) symbols. In this method, it also can be seen that the highestcurrent density occurs in the three dimensional surfaces of volumes 202a and 202 b that face one another. This results in creating thethickest, high viscosity surfaces 208 in the medial, anterior andposterior regions and the least “altered” surfaces in the laterallyoutward regions. This method is well suited for preventing posterior andanterior flows and directing retraction forces superiorly and inferiorlysince lateral flow are contained by the cortical bone at lateral aspectsof the vertebra. The system can further be adapted to switch ohmicheating effects between the bi-polar manner and the mono-polar mannerdescribed previously.

Now referring to FIG. 12, another embodiment is shown wherein atranslatable member 210 that functions as an electrode is carried byintroducer 110A. In a preferred embodiment, the member 210 is asuperelastic nickel titanium shape memory wire that has a curved memoryshape. The member 210 can have a bare electrode tip 212 with aradiopaque marking and is otherwise covered by a thin insulator coating.In FIG. 12, it can be seen that the introducer can be rotated and themember can be advanced from a port 214 in the working end 115A underimaging. By moving the electrode tip 212 to a desired location and thenactuating RF current, it is possible to create a local viscous orhardened region 216 of fill material 120. For example, if imagingindicates that fill material 120 is flowing in an undesired direction,then injection can be stopped and Rf energy can be applied to harden theselected location.

FIG. 13 illustrates another embodiment of the introducer 110A whichincludes a transition in cross-sectional dimension to allow fordecreased pressure requirements for introducing bone cement through thelength of the introducer. In the embodiment of FIG. 13, the proximalhandle end 106 is coupled to introducer 110A that has a larger diameterproximal end portion 218 a that transitions to a smaller diameter distalend portion 218 b configured for insertion into a vertebral body. Thedistal end portion 218 b includes exterior threads 222 for helicaladvancement and engagement in bone to prevent the introducer from movingproximally when cement is injected into a vertebral body or other bone,for example to augment vertebral height when treating a VCF. The borethat extends through the introducer 110A similarly transitions fromlarger diameter bore portion 224 a to smaller diameter bore portion 224b. The embodiment of FIG. 13 utilizes a bore termination or slot 225 ina sidewall of the working end 115A for ejecting bone cement at aselected radial angle from the axis 226 of the introducer for directingcement outflows within a vertebral body.

Still referring to FIG. 13, the introducer 110A is coupled to bonecement source 145 and pressure source 150 as described previously thatis controlled by controller 125B. Further, an energy source 125A (e.g.,Rf source) is coupled to an energy delivery mechanism in the working end115A for applying energy to a cement flow within bore 224 b. In theembodiment of FIG. 13, the introducer can be fabricated of a strongreinforced plastic such a polymide composite with a sleeve electrode 228in bore 224 a and inward of the bore termination slot 225, similar toelectrode 128 depicted in FIG. 3A. The electrode 228 in FIG. 13 iscoupled to Rf source 125A for operating in a mono-polar manner incooperation with a return ground pad indicated at 170. The controller125B again is operatively connected to Rf source 125A to adjust energydelivery parameters in response to feedback from a thermocouple 235 inthe bore 124 a or in response to measuring impedance of the cement flow.In FIG. 13, the controller 125B further is operationally connected to anaspiration source 240 that is coupled to a needle-like introducer sleeve242 that can be inserted into a bone to apply suction forces to theinterior of vertebra for relieving pressure in the vertebra and/orextracting fluids, bone marrow and the like that could migrate into thevenous system. The use of such an aspiration system will be describedfurther below.

In FIG. 13, the introducer 110A has a larger diameter bore 224 a thatranges from about 4 mm. to 10 mm. and preferably is in the range ofabout 5 mm to 6 mm. The smaller diameter bore 224 b can range from about1 mm. to 3 mm. and preferably is in the range of about 1.5 mm to 2.5 mm.The exterior threads 222 can be any suitable height with single or dualflights configured for gripping cancellous bone. The thread height andlength of the reduced diameter section 218 b are configured forinsertion into a vertebra so that the port 225 can be anteriorly orcentrally located in the vertebral body. The working end 115A furthercarries a radiopaque marking 244 for orienting the radial angle of theintroducer and bore termination port 225. In FIG. 13, the radiopaquemarking 244 is elongated and surrounds port 225 in the introducersidewall. The handle 106 also carries a marking 245 for indicating theradial angle of port 225 to allow the physician to orient the port byobservation of the handle.

Now referring to FIGS. 14A-14C, the working end 115A of the introducerof FIG. 13 is shown after being introduced into cancellous bone 122 invertebra 90. FIG. 14A illustrates a horizontal sectional view ofvertebra 90 wherein the bore termination port 225 is oriented superiorlyto direct cement inflows to apply forces against cancellous bone 122 andthe superior cortical endplate 248 of the vertebra. A method of theinvention comprises providing a flow source 250 (the pressure source 150and cement source 145, in combination, are identified as flow source 250in FIG. 13) for bone cement inflows and a controller 125B for control ofthe bone cement inflows, and inflowing the bone cement into a vertebralbody wherein the controller adjusts an inflow parameter in response to ameasured characteristic of the cement. In one method, the measuredcharacteristic is temperature of the bone cement measured bythermocouple 235 in the working end 115A. The controller 125B can be anycustom computerized controller. In one embodiment, the system canutilize a commercially available controller manufactured by EFD Inc.,East Providence, R.I. 02914, USA for flow control, wherein either apositive displacement dispensing system or an air-powered dispensingsystem can coupled to the flow source 250. In response to feedback fromthermocouple 235 that is read by the controller 125B, any inflowparameter of the bone cement flow can be adjusted, for example cementinjection pressure, the inflow rate or velocity of the bone cement flowsor the acceleration of a bone cement flow. The controller 125B also canvary any inflow parameter with time, for example, in pulsing cementinflows to thereby reduce a vertebral fracture, or move cancellous orcortical bone (see FIGS. 14A-14B). The cement 120 can be introduced insuitable volumes and geometries to treat fractures or toprophylactically treat a vertebra.

In another method corresponding to the invention, the flow source 250,controller 125B and Rf energy source 125A are provided as shown in FIG.13. The controller 125B again is capable of adjusting any bone cementdelivery parameter in response to impedance and/or temperature. Thecontroller 125B adjusts at least one cement delivery parameter selectedfrom cement volume, pressure, velocity and acceleration of the inflowingcement. The controller 125B also can vary pressure of the inflowingcement or pulse the cement inflows. In this embodiment, the controller125B also is capable of adjusting energy delivered from Rf energy source125A to the inflowing cement 120 in response to impedance, temperature,cement viscosity feedback or cement flow parameters to alter cementviscosity as described above. Cement viscosity can be calculated by thecontroller 125B from temperature and pressure signals. The controller125B also is capable of being programmed with algorithms to ramp-up andramp down power in one or more steps, or can be programmed to pulsepower delivery to the bone cement 120 (FIGS. 14A-14BA).

As can be seen in FIGS. 14B and 14C, the inflowing cement 120 can bedirected to apply forces against cancellous bone 122 and the superiorcortical endplate 248 of the vertebra, or the working end can be rotatedto introduce cement 120 and apply forces in other directions. In thisembodiment, the extension of the working end 115A in cancellous boneserves as a support for causing expansion pressures to be directedsubstantially in the direction of cement flows. The method of treatingthe vertebra includes translating (by helical advancement) and rotatingthe introducer 110A to thereby alter the direction of cementintroduction. In another embodiment (not shown), the introducer 110A cancomprise an assembly of first and second concentric sleeves wherein theouter sleeve has threads 222 for locking the assembly in bone and theinner sleeve is rotatable to adjust the angular direction of port 225wherein the sleeves are locked together axially. This embodiment can beused to intermittently angularly adjust the direction of cement outflowswhile helical movement of the outer sleeve adjusts the axial location ofport 225 and the cement outflows.

In another method of the invention, referring back to FIG. 14A, theaspiration introducer sleeve 242 can be inserted into the vertebralbody, for example through the opposing pedicle. The controller 125B canbe programmed to alter aspiration parameters in coordination with anybone cement inflow parameter. For example, the cement inflows can bepulsed and the aspiration forces can be pulsed cooperatively to extractfluids and potentially embolic materials, with the pulses synchronized.In one method, the cement inflows are pulsed at frequency rangingbetween about 1 per second and 500 per second with an intense, highacceleration pulse which causes bone marrow, fat, blood and similarmaterials to become susceptible to movement while at the same time theaspiration pulses are strong to extract some mobile marrow etc. into theaspiration sleeve 242. In FIG. 14A, the aspiration sleeve 242 is shownwith single port in it distal end. It should be appreciated that thescope of the invention and its method of use includes an aspirationsleeve 242 that has a plurality of inflow ports along the length of thesleeve and the sleeve also can be curved or can be of a shape memoryalloy (e.g., Nitinol) to for introduction in a curved path in theanterior of posterior region of a vertebral body as indicated by lines260 and 260′ in FIG. 14A. In another embodiment, the aspiration sleeve242 can extend through the introducer 110A or can comprise an outerconcentric sleeve around the introducer 110A.

FIGS. 15A and 15B illustrates another method corresponding to theinvention wherein the controller 125B and pressure source 150 areconfigured to introduce a flowable cement into the interior of avertebra one under widely varying velocities and rates of accelerationto optionally (i) provide first slow flow rates to allow cement flow andinterdigitition into and through cancellous bone, and (ii) providesecond higher flow rates that disallow cement interdigitition and flowinto and through cancellous bone. At suitable high acceleration and flowvelocity, for example in a pulse of cement flow into bone, theaccelerated flow apply forces to bone substantially across the surfaceof the cement plume which can displace cancellous bone rather thanallowing the cement to flow into the cancellous bone. FIG. 14Aillustrates the system of FIG. 13 in a method of use wherein thecontroller 125B and pressure source 150 are actuated to cause a volumeof cement 120 to flow into cancellous bone 122 under a suitable lowpressure to allow the cement to interdigitate with, and flow into, thecancellous bone. The flow of cement depicted in FIG. 14A can beaccompanied by the application of aspiration forces as described above.FIG. 15B illustrates another aspect of the method wherein the controller125B and pressure source 150 are actuated to flow cement with a highacceleration rate and velocity that disallows the cement from havingtime to flow into pores of the cancellous bone. The acceleration andvelocity are selected to disallow cement interdigitation which therebycauses the application of force to bone across the surface of the cementplume 265 (FIG. 15B). The application of such forces across the surfaceof cement plume 265 is further enabled by providing a suitable highviscosity cement as described above, which includes selectivelyincreasing cement viscosity by means of energy delivery thereto. Themethod of the invention can include one or more sequences of flowingcement into the bone to first cause cement interdigitation (FIG. 15A)and then to apply expansion forces to the bone by at least one highacceleration flow (FIG. 15B). Of particular interest, the method ofusing high acceleration flows, for example in pulses, causes the cementvolume to apply forces to bone akin to the manner is which a mechanicalexpander or balloon expander would apply forces to bone. That is,expansion forces are applied across the entire surface of cement plume265 similar to then manner in which mechanical instruments applyexpanding forces across the bone engaging surface of the instrument. Themethods are adapted for reducing a vertebral fracture and forselectively applying forces to move cancellous bone and cortical bone.

The scope of the invention further extends to cure-on-demand fillmaterials that can be used for disc nucleus implants, wherein theconductive fill material is injected to conform to the shape of a spaceand wherein Rf current is then applied to increase the modulus of thematerial on demand to a desired level that is adapted for dynamicstabilization. Thus, the Rf conductive fill material 120 can beengineered to reach a desired modulus that is less than that of ahardened fill material used for bone support. In this embodiment, thefill material is used to support a disc or portion thereof. Thecure-on-demand fill material also can be configured as an injectablematerial to repair or patch a disc annulus as when a tear or herniationoccurs.

The scope of the invention further extends to cure-on-demand fillmaterial that can be used for injection into a space between vertebraefor intervertebral fusion. The injection of fill material can conform toa space created between two adjacent vertebrae, or can be injected intonotches or bores in two adjacent vertebrae and the intervening space,and then cured by application of Rf current to provide a substantiallyhigh modulus block to cause bone fusion.

In any embodiment such as for intervertebral fusion or for bone supportin VCFs, the system can further include the injection of a gas (such ascarbon dioxide) into the fill material before it is injected from a highpressure source. Thereafter, the gas can expand to form voids in thefill material as it is cured to create porosities in the hardened fillmaterial for allowing rapid bone ingrowth into the fill material.

In related methods of the invention, the system of the invention can useany suitable energy source, other that radiofrequency energy, toaccomplish the purpose of altering the viscosity of the fill material120. The method of altering fill material can be at least one of aradiofrequency source, a laser source, a microwave source, a magneticsource and an ultrasound source. Each of these energy sources can beconfigured to preferentially deliver energy to a cooperating, energysensitive filler component carried by the fill material. For example,such filler can be suitable chromophores for cooperating with a lightsource, ferromagnetic materials for cooperating with magnetic inductiveheating means, or fluids that thermally respond to microwave energy.

The scope of the invention includes using additional filler materialssuch as porous scaffold elements and materials for allowing oraccelerating bone ingrowth. In any embodiment, the filler material cancomprise reticulated or porous elements of the types disclosed in U.S.patent application Ser. No. 11/146,891, filed Jun. 7, 2005, titled“Implants and Methods for Treating Bone” which is incorporated herein byreference in its entirety and should be considered a part of thisspecification. Such fillers also can carry bioactive agents. Additionalfillers, or the conductive filler, also can include thermally insulativesolid or hollow microspheres of a glass or other material for reducingheat transfer to bone from the exothermic reaction in a typical bonecement component.

The above description of the invention is intended to be illustrativeand not exhaustive. Particular characteristics, features, dimensions andthe like that are presented in dependent claims can be combined and fallwithin the scope of the invention. The invention also encompassesembodiments as if dependent claims were alternatively written in amultiple dependent claim format with reference to other independentclaims. Specific characteristics and features of the invention and itsmethod are described in relation to some figures and not in others, andthis is for convenience only. While the principles of the invention havebeen made clear in the exemplary descriptions and combinations, it willbe obvious to those skilled in the art that modifications may beutilized in the practice of the invention, and otherwise, which areparticularly adapted to specific environments and operative requirementswithout departing from the principles of the invention. The appendedclaims are intended to cover and embrace any and all such modifications,with the limits only of the true purview, spirit and scope of theinvention.

Of course, the foregoing description is that of certain features,aspects and advantages of the present invention, to which variouschanges and modifications can be made without departing from the spiritand scope of the present invention. Moreover, the bone treatment systemsand methods need not feature all of the objects, advantages, featuresand aspects discussed above. Thus, for example, those skill in the artwill recognize that the invention can be embodied or carried out in amanner that achieves or optimizes one advantage or a group of advantagesas taught herein without necessarily achieving other objects oradvantages as may be taught or suggested herein. In addition, while anumber of variations of the invention have been shown and described indetail, other modifications and methods of use, which are within thescope of this invention, will be readily apparent to those of skill inthe art based upon this disclosure. It is contemplated that variouscombinations or subcombinations of these specific features and aspectsof embodiments may be made and still fall within the scope of theinvention. Accordingly, it should be understood that various featuresand aspects of the disclosed embodiments can be combined with orsubstituted for one another in order to form varying modes of thediscussed bone treatment systems and methods.

What is claimed is:
 1. An apparatus for delivering a bone cement into abone, comprising: a bone cement injector having an internal flow channelextending therethrough to at least one outlet in a distal end of theinjector, wherein an interior surface of the internal flow channelcomprises a polymeric layer; a thermal energy emitter coupleable to anelectrical source and configured to deliver energy to the bone cement asit flows through the internal flow channel of the bone cement injector,wherein the interior surface is insulative from the thermal energyemitter; and a sensor configured to provide a measurement of a parameterof the bone cement as it flows through the internal flow channel.
 2. Theapparatus of claim 1, wherein the polymeric layer is thermally andelectrically insulative.
 3. The apparatus of claim 1, wherein thepolymeric layer comprises a material selected from the group consistingof PEEK (Polyetheretherketone), Teflon™, and a polyimide.
 4. Theapparatus of claim 1, wherein the thermal energy emitter comprises atleast one conductor coupled to an electrical source.
 5. The apparatus ofclaim 4, wherein the at least one conductor comprises a resistiveheating element.
 6. An apparatus for delivering a bone cement into abone, comprising: a bone cement injector extending from a proximal endto a distal end and having at least one outlet at the distal end of theinjector, at least a portion of the injector being removablypositionable in bone the bone cement injector having an internal flowchannel extending from the proximal end to the at least one outlet; athermal energy emitter operably coupled to the internal flow channelextending through the bone cement injector, the thermal energy emittercoupleable to an electrical source and configured to deliver energy tobone cement flowing through the internal flow channel; a polymeric layerextending along at least a portion of the internal flow channel, thepolymeric layer configured to contact bone cement flowing through theinternal flow channel to facilitate the flow of the bone cement throughthe injector and into the bone, wherein the polymeric layer isinsulative from the thermal energy emitter; and a sensor configured toprovide a measurement of a parameter of the bone cement prior to thebone cement flowing through the at least one outlet at the distal end ofthe injector.
 7. The apparatus of claim 6, wherein the polymeric layeris thermally and electrically insulative.
 8. The apparatus of claim 6,wherein the polymeric layer comprises a material selected from the groupconsisting of PEEK (Polyetheretherketone), Teflon™, and a polyimide. 9.The apparatus of claim 6, wherein the thermal energy emitter comprisesat least one conductor coupled to an electrical source.
 10. Theapparatus of claim 9, wherein the at least one conductor comprises aresistive heating element.
 11. An injector system comprising anapparatus for delivering a bone fill material to a vertebra, comprising:an injector assembly having portion positionable within a bone, theinjector having a polymeric surface layer that defines an internal flowchannel extending through the injector to at least one outlet opening;and a thermal energy emitter operatively coupled to the internal flowchannel and configured to a ply energy to the bone fill material flowingthrough the internal flow channel, wherein the polymeric surface layeris insulative from the thermal energy emitter, a first portion of thepolymeric surface layer disposed radially between the thermal energyemitter and the internal flow channel and a second portion of thepolymeric surface layer extending downstream from the thermal energyemitter to the at least one outlet opening; and a sensor configured toprovide a measurement of a parameter of bone fill material flowingthrough the internal flow channel.
 12. The system of claim 11, whereinthe polymeric surface layer is thermally and electrically insulative.13. The system of claim 11, wherein the polymeric surface layercomprises a material selected from the group consisting of PEEK(Polyethylethylketone), Teflon™, and polyimide.
 14. The system of claim11, wherein the thermal energy emitter comprises at least one conductorcoupled to an electrical source.
 15. The system of claim 14, wherein theat least one conductor comprises a resistive heating element.